SUNLIGHT: Who is eligible to join?

People are eligible if they:

  1. Are 18 years and older and have been diagnosed with metastatic unresectable cancer of the colon or rectum
  2. Have received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
  3. Have measurable or non-measurable disease as defined by RECIST version 1.1
  4. Are able to swallow oral tablets
  5. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  6. Have an estimated life expectancy of ≥12 weeks
  7. Have no RAS mutations present in their tumor
  8. Have already been treated with fluoropyrimidines, oxaliplatin, irinotecan, and anti-VEGF antibodies

People are not eligible if they:

  • Have had more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer
  • Are pregnant, a lactating female, or have the possibility of becoming pregnant during the study
  • Are currently receiving or have received anticancer therapies within 4 weeks prior to randomization
  • Have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation)
  • Have symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
  • Have severe or uncontrolled active acute or chronic infection.
  • Have active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension
  • Have a known Hepatitis B or Hepatitis C Virus infection
  • Are known carriers of HIV antibodies
  • Have confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia
  • Have had deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
  • Have had treatment with any of the following within the specified time frame prior to randomization:
    • Major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
    • Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only
    • Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
    • Other clinically significant medical conditions
    • Other malignancies

There are additional eligibility requirements for this study: see the complete list at clinicaltrials.gov. Contact your doctor if you are unsure of your eligibility. You can also contact a study doctor who will review the criteria with you and help determine your eligibility.

For more information, email [email protected]
or call Karim Benhadji, MD at 1-609-250-7336.